BVL公司（美国注射剂生产商）FDA检查缺陷.pdfVIP

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMJNISTRAilON DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION 6751 Steger Drive Cincinnati, Ohio 4523 7 FEI NUMBER 1519257 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED TO: Thomas J. Murphy, President CEO l_:_:~=:=.~=l-~-~-~-u-~-N-~-~-:_z~-~~~6-~a~:-;~~=·e__s_~·-··I_.-n~c~.=~--~·-.. ~=·~-~--~~--~-~--·_ ... _·_·-·_·--_-.-~..·--··-[i];~~~~=~;•o .--~-=~~- -~·--_ DURING AN INSPECTrON OF YOUR FIRM {I) (liVE} OBSERVED: This document lists observations made by the FDA representative{s) durjng the inspection. ofyour facility. They are inspectiona1 observations, and do not represent a final Agency detem1ination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation~ you may discuss the objection or ac.,iion with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the telephone number and address above, During an Inspection ofyour facility we observed. 1. The Quality Manual, document #030-SOP-OP-01340, dated 28 Feb 2011, ~describes the pharmaceutical quality system (PQS) as implemented at BVL. The Quality Manual identifies the elements of the PQS and the sequences, linkages, and interdependencies of related processes, and the responsibilities of Management to ensure effective implementation.